Therapeutic combination comprising a pulmonary surfactant and a steroid for the treatment of evolving bpd

Abstract

Administering a pulmonary surfactant and a corticosteroid is effective for the treatment of evolving bronchopulmonary dysplasia (BPD) in preterm neonates.

1 . A composition, comprising:
 (a) at least one pulmonary surfactant; and   (b) budesonide,   wherein said budesonide is present in an amount sufficient to deliver a dose of 0.1 to 1.5 mg/kg to a preterm neonate.   
     
     
         2 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of 0.2 to 1.0 mg/kg to a preterm neonate. 
     
     
         3 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of 0.1 to 0.5 mg/kg to a preterm neonate. 
     
     
         4 . A composition according to  claim 1 , which comprises budesonide in an amount sufficient to deliver a dose of 0.5 to 1.0 mg/kg to a preterm neonate. 
     
     
         5 . A composition according to  claim 1 , which comprises said at least one pulmonary surfactant in an amount sufficient to deliver a dose of 100 to 200 mg/kg a preterm neonate. 
     
     
         6 . A composition according to  claim 1 , which comprises poractant alfa. 
     
     
         7 . A composition according to  claim 1 , which is in a form of an aqueous suspension comprising a pharmaceutically acceptable carrier. 
     
     
         8 . A composition, comprising:
 (a) 20 to 100 mg/ml of at least one pulmonary surfactant; and   (b) 0.05 to 0.5 mg/ml of budesonide.   
     
     
         9 . A kit, comprising:
 (a) a pulmonary surfactant in an amount sufficient to deliver a dose of 100 to 200 mg/kg, to a preterm neonate, and a pharmaceutically acceptable carrier or diluent in a first unit dosage form;   (b) budesonide in an amount sufficient to deliver a dose of dose of 0.1 to 1.5 mg/kg, to a preterm neonate, and a pharmaceutically acceptable carrier or diluent in a second unit dosage form; and   (c) a container for containing said first and second dosage forms.   
     
     
         10 . A method for the treatment of evolving bronchopulmonary dysplasia (BPD) in a preterm neonate, comprising administering to a preterm neonate at least one pulmonary surfactant and budesonide in a dose of 0.1 to 1.5 mg/kg. 
     
     
         11 . A method according to  claim 10 , wherein said pulmonary surfactant and budesonide are administered from the 2 nd  to the 28 th  day of life of the preterm neonate. 
     
     
         12 . A method according to  claim 10 , wherein said pulmonary surfactant and budesonide are administered from the 5 th  to the 15 th  day of life. 
     
     
         13 . A method according to  claim 10 , wherein said pulmonary surfactant and budesonide are administered from the 7 th  to the 10 th  day of life. 
     
     
         14 . A method according to  claim 10 , wherein said preterm neonate is kept under a non-invasive ventilation procedure. 
     
     
         15 . A method according to  claim 10 , wherein said non-invasive ventilation procedure is nasal CPAP. 
     
     
         16 . A method according to  claim 10 , wherein said budesonide is administered at a dose of 0.2 to 1.0 mg/kg. 
     
     
         17 . A method according to  claim 10 , wherein said budesonide is administered at a dose of 0.1 to 0.5 mg/kg. 
     
     
         18 . A method according to  claim 10 , wherein said budesonide is administered at a dose of 0.5 to 1.0 mg/kg. 
     
     
         19 . A method according to  claim 10 , wherein said at least one pulmonary surfactant and budesonide are administered simultaneously. 
     
     
         20 . A method according to  claim 10 , wherein said at least one pulmonary surfactant and budesonide are administered sequentially. 
     
     
         21 . A method according to  claim 10 , wherein said at least one pulmonary surfactant and budesonide are administered separately. 
     
     
         22 . A method according to  claim 10 , comprising administering said at least one pulmonary surfactant at a dose of 100 to 200 mg/kg. 
     
     
         23 . A method according to  claim 10 , comprising administering poractant alfa. 
     
     
         24 . A method according to  claim 10 , wherein said administering is administration by inhalation or intratracheal route. 
     
     
         25 . A method according to  claim 10 , wherein said at least one pulmonary surfactant and budesonide are administered in the form of an aqueous suspension comprising a pharmaceutically acceptable carrier.